NDC 0378-3458

Azelastine Hydrochloride and Fluticasone Propionate

Azelastine Hydrochloride And Fluticasone Propionate

Azelastine Hydrochloride and Fluticasone Propionate is a Nasal Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Azelastine Hydrochloride; Fluticasone Propionate.

• Product ID: 0378-3458_09e46ec2-47a4-4c32-aae9-66ace51b09dd
• NDC: 0378-3458
• Product Type: Human Prescription Drug
• Proprietary Name: Azelastine Hydrochloride and Fluticasone Propionate
• Generic Name: Azelastine Hydrochloride And Fluticasone Propionate
• Dosage Form: Spray, Metered
• Route of Administration: NASAL
• Marketing Start Date: 2020-04-14
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA202236
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
• Active Ingredient Strength: 137 ug/1; ug/1
• Pharm Classes: Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0378-3458-23

1 BOTTLE in 1 BOX (0378-3458-23) > 120 SPRAY, METERED in 1 BOTTLE

• Marketing Start Date: 2020-04-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-3458-23 [00378345823]

Azelastine Hydrochloride and Fluticasone Propionate SPRAY, METERED

• Marketing Category: NDA authorized generic
• Application Number: NDA202236
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2020-04-14

Drug Details

Active Ingredients

Ingredient	Strength
AZELASTINE HYDROCHLORIDE	137 ug/1

OpenFDA Data

• SPL SET ID: 7b5cc5a0-0d47-46b5-b5fb-eb9cc248ae9e
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 0L591QR10I
  • O2GMZ0LF5W
• RxNorm Concept Unique ID - RxCUI:
  • 1797847

Pharmacological Class

• Histamine H1 Receptor Antagonists [MoA]
• Histamine-1 Receptor Antagonist [EPC]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "Azelastine Hydrochloride and Fluticasone Propionate" or generic name "Azelastine Hydrochloride And Fluticasone Propionate"

NDC	Brand Name	Generic Name
0378-3458	Azelastine Hydrochloride and Fluticasone Propionate	Azelastine Hydrochloride and Fluticasone Propionate
45802-066	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride, fluticasone propionate
60505-0953	Azelastine hydrochloride and Fluticasone propionate	Azelastine hydrochloride and Fluticasone propionate
63629-8612	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride, fluticasone propionate
0037-0245	DYMISTA	Azelastine Hydrochloride and Fluticasone Propionate
69621-812	Ticalast	azelastine hydrochloride and fluticasone propionate